Patent Games Cannot Save Blockbuster Remicade Patent

In an ex parte reexamination of U.S. Patent No. 6,284,471, the Patent Trial and Appeal Board affirmed the examiner’s conclusions that NYU’s claims unpatentable under the judicial doctrine of obviousness-type double patenting. NYU and J&J have played a few games with this particular patent family of 30+ patents. The claims relate to antibodies and assay methods associated with a tumor necrosis factor (TNF) and is said to cover J&J’s blockbuster drug Remicade used to treat so-called autoimmune diseases.

The Patent Act text appears to allow a patentee to obtain multiple patents covering similar inventions. However, the judicially created doctrine blocking double-patenting limits that approach. The most poignant need for the OTDP doctrine arose pre-GATT when a patent’s term extended for 17 years beyond its issue date. In that legal framework, a patentee could seemingly file a series of continuation applications that included obvious modifications to claim scope but in order to continually refresh the patent term. Thus, the Federal Circuit has explained:

The doctrine of obviousness-type double patenting is intended to prevent the extension of the term of a patent by prohibiting the issuance of the claims of a second patent that are not patentably distinct from the claims of the first patent.”

G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1351 (Fed. Cir. 2015) (citing Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376 (Fed. Cir. 2012)). This concern has largely been eliminated since patent terms are now calculated based upon priority filing dates. In addition, it is unclear the extent that the doctrine survives the modifications of the America Invents Act. These concerns though are irrelevant to this case since it is a pre-GATT case.

A twist on the OTDP doctrine comes from 35 U.S.C 121 which has been interpreted to prohibit claims in a divisional application (filed following a restriction requirement) from being cancelled or rejected based upon the parent application.

Here indeed, the parent application was subject to a 5-way restriction requirement. However, rather than limiting the claims and filing a divisional, NYU abandoned the original application and filed two separate continuation-in-part applications — in both cases adding new matter. According to the Federal Circuit, without a divisional, Section 121 safe harbor does not apply.

The § 121 safe harbor, “by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications.” Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir. 2008) (internal quotation marks omitted). Accordingly, patents issued on CIP applications are not within the scope of § 121. Nor are patents issued on continuation applications. Amgen. Our precedent is clear: aside from the original application and the original patent, the protection afforded by § 121 is limited to divisional applications and patents issued on divisional applications.

The precedent above is not new and was well known to the patentee here by the time of this dispute. Thus, during the reexamination the patentee attempted to retroactively amend its filing to transform the application from a continuation-in-part into a divisional application. The Federal Circuit has rejected that approach:

In Searle we answered this question in the reissue context, holding that the patent owner could not take advantage of the safe-harbor provision simply by designating the CIP as a divisional application in a reissue application years after the fact. . . . We are persuaded by the reasoning in Searle that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.

67 thoughts on “Patent Games Cannot Save Blockbuster Remicade Patent”

Why did you refer to auto-immune diseases as “so-called”? This seems to imply some inappropriateness to the term. “So-called” is also used to reference a common-designation, but if that is your intention, why include it at all?

As the Fed. Cir. has noted in other cases, while “The doctrine of obviousness-type double patenting is intended to prevent the extension of the term of a patent,” that is not its only intent. It also protects companies from plural patent suits from plural patents with claims to the same invention if any of the plural patents no longer remain owned by the same patent owner.

Also Paul, just as one cannot multiply the damages by having multiple claims of a patent infringed, one should not be able to multiply damages by spreading the claims to a single invention over multiple patents.

I am not blind to the implication, but it is only that. There can be a myriad of reasons why the section you quoted is true. There was no evidence that the current state of the patent system in the US is a factor, let alone a significant factor in research and development spending and concentration of high-tech public companies being lower in the US. Additionally, any such analysis would have to include a comparative analysis of the patents systems that are in the top 10 countries and the US. In the contrary, the US seems to score high on high-tech density (#1),patent activity (#2), and R&D intensity (#10), which would be the natural starting places to judge the state of the patent system. We seems to lag in manufacturing added value (#23) and tertiary efficiency (#40), which are not nature starting places to judge the state of the patent system.

All I ask for is actual evidence of causation to show that current patent policy is affecting the nebulous concept of innovation. I am apparently burning down the patent system for the sin of asking for evidence.

The link you augustly provided describes the natural business cycle of any company. To get your slice of the pie, you have to do things differently. Once you get your slice of the pie, you must do what you can against those who would think differently. It is a tale as old as time as yesterday’s upstarts become today’s dinosaurs. It true in the past, it is true now, and it will be true in the future.

Also, Ordinary, your comments about Google are just strange. The point is what is good for the USA and not what is good for Google. And, what Google has become is certainly partly due to the current political and legal structure of the USA. You should care more about what is good for the USA and write about corruption and monopolies as if they are normal and OK.

Except that it makes no difference where R&D is located in terms of patent protection. A South Korean company can apply for a US patent and a US company can apply for a South Korean patent. So why would someone move their company to South Korea because they have a more favorable patent system?

What has been shown to happen is that the location of R&D is most beneficial when it is CO-located with manufacturing; and the US has suffered a severe “hollowing out” of manufacturing based on cost factors.

I am sure that I grow tedious in repeating this point, but the U.S. patent system does not incentivize exclusively U.S. innovation. Did you notice the part in the linked article where it mentioned that “Samsung Electronics… has received more U.S. patents in the 2000s than any firm except [IBM]…”? That is because U.S. patents incentivize Korean firms just as much as U.S. patents incentivize U.S. firms.

In other words, while I would wholeheartedly welcome Congressional action to fix the numerous flaws that the SCotUS and (to a much lesser extent) the CAFC have created in our patent system, none of this would do anything to improve the relative U.S. position in innovation relative to other nations. Any improvement in the incentives provided by U.S. patents should be expected spur just as much increase in (e.g.) Korean innovation as in U.S. innovation.

Incidentally, did you notice that the criteria used to calculate this index score “includ[e] research and development spending… .” That means that we could boost our score in the innovation index by pouring an extra $100 billion into research on perpetual motion machines. Does anyone think that there would be a big pay-off in actual innovation from that spending? In other words, the Bloomberg index is kind of a useless indicator.

Also, did you notice that “[t]he U.S. fell to 11th place from ninth mainly because of an eight-spot slump in the post-secondary, or tertiary, education-efficiency category.” In other words, we are not retaining enough of the STEM grads that our U.S. universities produce. Perhaps, then, if we really care about this (rather dubious) Bloomberg innovation score, we might want to think about being more attractive to immigrants, rather than trying to stop them from coming or to drive them out once they are here. We need more immigrants to boost innovation, and yet all of the effort in Congress right now is (perversely) to reduce the number of immigrants that we let in. We are cutting off our noses to spite our faces.

Greg, that is a point well worth repetition. The important fact that half of all U.S. patent applications are by foreign companies is usually ignored here and on IPWatchdog in discussions or allegations of the economic impacts of U.S. patent law.

What about? How to make engineers friendlier to gay people specifically? How to successfully transition from f/m or m/f? How to successfully tear down the oppressive white cis hetero christian patriarchy capitalist system?

If that’s your proposed research topic do you really think that an R/D project to find out requires taxing the rich?

I’m going to go out on a limb and say there are probably a great deal more since we’re all science and engineering edumcated (bastions of the white cis hetero christian deplorable capitalist patriarchy in university by all accounts). Although we have only begun to break the previous conditioning. Strictly deplorable PTO SOOOOOOOOON! Just the other day a lefty grl I know here who liked to wear a “hillary suit” now warms to donny t (that cash money was more than enough for her lol).

I’m a white, cis, hetero, culturally-christian (I don’t buy the supernatural stuff, but enjoy and value my parish culture), capitalist, patriarch–I won’t own to the deplorable part. I think we should increase the NASA R&D budget by an order of magnitude. Likewise, I have first-hand experience with the successful private commercialization of DOE- and DOD-funded big business R&D. This type of R&D is an excellent investment of taxpayer money.

“I’m a white, cis, hetero, culturally-christian (I don’t buy the supernatural stuff, but enjoy and value my parish culture), capitalist, patriarch–I won’t own to the deplorable part. I think we should increase the NASA R&D budget by an order of magnitude.”

Duh, so do nearly all white cis hetero christian capitalist patriarchs. Whatever you and a bunch of white cis hetero christian patriarchs wants takes a back seat to diversity and inclusion. Otherwise you’re a white supremacist. Don’t forget that. Also don’t forget that science is raycyst and discourages “other ways of knowing” while being a tool of white supremacy. I literally didn’t make any of that that up, there is a whole leftist media conglomerate dedicated to pushing that nonsense.

“Likewise, I have first-hand experience with the successful private commercialization of DOE- and DOD-funded big business R&D. This type of R&D is an excellent investment of taxpayer money.”

I doubt MM would go for those kinds of funding. He’s literally against DOD spending, maybe he might go for some DOE as long as those hired are diverse enough. Otherwise no dice I’d bet.

“In other words, we are not retaining enough of the STEM grads that our U.S. universities produce”

Trump already noted as much and said he’d like to keep more, but the dirty dirty raycyst (against the graduate’s ethnicities) muh victim mongers insist on keeping the muh victims before the muh graduates.

“Bloomberg innovation score, we might want to think about being more attractive to immigrants, rather than trying to stop them from coming or to drive them out once they are here. ”

We’re already 100000% attractive. That needs no work. All they need is the ability to legally stay without having to get married upon graduating to an american instead of say, oh I don’t know, a muh victim coming in their place.

But if you say this then lefties go nuts about their muh raycysm muh racysm muh raycysm since, spoiler alert, most of those graduates not being kept are not the most especial kind of muh victim to leftists.

Although layered on top of this is the concern that currently many universities are using foreign students as just a way to make $$$$ ez (intl tuition is sky high), so they just let in a huge number of foreign students to make $$$$. And that might be more than the US actually needs to add to its worker pool in a given sector. And that’s setting to the side concerns about lessening wages (which go up with fewer workers in the sector generally).

Ned – I’m far outside my area of expertise here, but it may have something to do with Ireland’s traditionally favorable tax rules and/or Apple’s large presence in Ireland. Apple used to book a lot of profits through Ireland, but transitioned to Jersey when the EU told Ireland it had to be more strict in its tax policies. I believe, however, that Apple still has a large presence in Ireland, second in Europe only to the UK.

I suppose that I cannot blame J&J for trying here, but this was one of the weakest arguments that I think that I have ever heard made to the CAFC. This case turned out exactly as one would expect. If J&J had won this case, then the lawyer who won it for them could be fast-tracked for sainthood, because he would have already had one miracle to his record.

“Here indeed, the parent application was subject to a 5-way restriction requirement. However, rather than limiting the claims and filing a divisional, NYU abandoned the original application and filed two separate continuation-in-part applications — in both cases adding new matter. ”

Your straw man is unavailing. Where does this “regional circuit” desire arise from in the present case? How in the world would going down that FAILED experiment again change THIS case in any way, shape or form?

Dennis should try a 6 week ban of you, MM, Ned Heller, and all of your alternate accounts. One of two things will happen. Either the level of discussion will rise substantially, or it will be utter silence here. If the latter, he can rescind the ban.

Or, he can post a single policy that applies to all and enforce that single policy objectively.

I “Get” that you do not like your little straw man attempt called out for its weakness, and would rather merely have your turn atop the stump with NO critical thinking applied to what you want to say, but that’s not what the opportunity for dialogue entails.

anony reminds me of the type of people all too eager to tell the wrong people to just s h u t up.

He wants his pedestal, but does not want any thinking about what he unleashes from his pedestal.

Instead of engaging on the merits or content, he wants a ban.
Instead of backing up his statement that I was “wrong” about what a straw man is – and that was exactly what he presented – he calls names, goes ad hominem in a mindless manner (the glug glug path), and then has the audacity to want to ban my correct comment which evidences critical thinking (but thinking he does not like).

The better path anony is to engage – and realize when YOU have mis-stepped.

I think that the editorial controls remain in flux and that other changes to the comment sections may be being experimented upon.

ONE thing though that has to go is the “penalty” for having dialogue with the blind application of the “count” filter.

The immediate impact of that filter is that dialogue stops – and that plays directly into the hands of the “Drive-by Monologues” ‘style‘ of posting, which is to say, the posting ‘style‘ emblematic of blight.

Anony, this was from an ex parte reexamination, not an IPR as is being attacked in Oil States. [But whether or not that is a valid constitutional difference is one one of the issues poorly argued in that case.]

It would become VERY pertinent if IPRs were held unconstitutional on unconstitutionality grounds also applicable to ex parte reexaminations, whether argued by the parties in Oil States or not. Hopefully the Sup. Ct. will consider that.

Paul, even though Oil States conceded that reexaminations were constitutional – somehow distinguishing McCormick Harvesting even though relying upon it to support its own case, it was clear that Justice Gorsuch was not buying it, openly quoting from McCormick Harvesting.

So the fate of reexaminations actually is still in the balance despite Oil States “valiant” efforts to preserve to their constitutionality.

I can only hope that the Supreme Court decides that IPR are unconstitutional, but they going to have to do so despite the “best efforts” of Oil States.